Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Cohort I (DTG 50 mg OD)

Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).

Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, and 96

Measure Description

Change from Baseline in CD4+ cell count was assessed at Day 11 and at Weeks 4, 12, 24, 48, 72, and 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Time Frame

Baseline; Day 11; Weeks 4, 12, 24, 48, 72, and 96

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

ITT-E Population. Only those participants available at the indicated time points were analyzed.

Reporting Groups

Description

Cohort I (DTG 50 mg OD)

Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).

As of the data cut-off, Week 48 is the last time point which all participants in Cohort II would have had opportunity to reach if they had not discontinued prematurely. No data were available for analysis at this time point.

No statistical analysis provided for Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, and 96

Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences [ Time Frame: From the day of the first dose of study drug to the data cut-off (median 86 weeks for Cohort I, median 49 weeks for Cohort II ]

Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death [ Time Frame: From the day of the first dose of study drug to the data cut-off (median 86 weeks for Cohort I, median 49 weeks for Cohort II ]

Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance [ Time Frame: From Baseline (Day 1) to the data cut-off (median 86 weeks for Cohort I, median 49 weeks for Cohort II) ]

Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance [ Time Frame: From Baseline (Day 1) to the data cut-off (median 86 weeks for Cohort I, median 49 weeks for Cohort II) ]

Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities [ Time Frame: From the day of the first dose of study drug to the data cut-off (median 86 weeks for Cohort I, median 49 weeks for Cohort II) ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.